Zerit is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS.

Zerit may also be used for other purposes not listed.

INSTRUCTIONS

Take Zerit exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Zerit comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take Zerit with a full glass of water.

Zerit can be taken with or without food.

DOSAGE

The recommended dose for adults is 40 mg twice daily for those weighing 60 kg or more and 30 mg twice daily if less than 60 kg. Children weighing less than 30 kg should receive 1 mg/kg. Children weighing 30 kg or more should be treated like adults. Zerit may be administered without regard to meals.

Throw away any leftover medication after 30 days. Throw away any unused or expired Zerit in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

MORE INFO:

Active Ingredient: stavudine

Do NOT use Zerit if:

you are allergic to stavudine.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Zerit, tell your doctor if you are allergic to any drugs, or if you have:kidney disease;liver disease;diabetes; ora history of pancreatitis.

Some people have developed a life-threatening condition called lactic acidosis while taking Zerit. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Zerit can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking Zerit: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

FDA pregnancy category C. It is not known whether Zerit is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Zerit may also be more likely to cause lactic acidosis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

You should not breast-feed while you are using Zerit. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Important safety information:

Before taking Zerit, tell your doctor if you are using any of the following drugs:

didanosine (Videx);

doxorubicin (Adriamycin);

hydroxyurea (Droxia, Hydrea);

interferon-alfa (Roferon, Intron, Rebetron);

ribavirin (Rebetol, Ribasphere, Copegus Virazole); or

zidovudine (Retrovir).

This list is not complete and there may be other drugs that can interact with Zerit. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include numbness, burning, pain, or tingly feeling, nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Avoid drinking alcohol while taking Zerit. Alcohol may increase the risk of damage to the pancreas and/or liver.

Taking Zerit will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Stop using Zerit and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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